HealthyPhase 1/2NCT01117727
Sensorimotor Rhythm Brain-Computer Interface Switch to Operate Assistive Technology
A Phase 1/2 study testing Brain Computer Interface Switch in people with Healthy, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this research is to develop tools to help people who are paralyzed. These tools are called brain-computer interfaces (BCIs). BCIs would allow a person to use brain signals to operate technology. Specifically this project's goal is to design a BCI to operate a switch. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Brain Computer Interface Switch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Dec 2012
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Able to read text on a computer screen
- Able to understand and remember instructions concerning participation
Who cannot join
- Unable to give informed consent
- Unable to understand and follow instructions
- Have abnormal tone or uncontrolled movements in the head-and-neck that would interfere with EEG recordings
- Known to have photosensitive epilepsy
- Open head lesions or sores
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Direct Brain Interface Project
Ann Arbor, Michigan, 48108
About this study
The purpose of this research is to develop tools to help people who are paralyzed. These tools are called brain-computer interfaces (BCIs). BCIs would allow a person to use brain signals to operate technology. Specifically this project's goal is to design a BCI to operate a switch.
Read the detailed description
The investigators want to make a BCI that can be used to operate commercially available technologies for communication, environmental control or computer access. The BCI would replace a switch to let people operate these technologies without moving. However, investigators need people to test the BCI so they can determine how effective it is in replacing a switch.
- Conditions
- Healthy
- Being tested
- Brain Computer Interface Switch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Computer Interface SwitchDevice
Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 14-20 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Pilot Testing | Experimental | Not described Receives: Device: Brain Computer Interface Switch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Using the BCI as a Switch to Select From 4 Targets Using Scanning
Average accuracy for selecting one of 4 targets with a switch operated by a brain-computer interface controlled by power in the sensorimotor rhythms. The 8 sessions were conducted over a 2 month period. Accuracy was calculated as the percentage of trials in which the target was correctly selected. Trials for all sessions were combined to create the overall average. Therefore, there is no standard deviation. .
Measured: 8 sessions over 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Performance of BCI switch insufficient in pilot testing.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jane Huggins, PhD, University of Michigan
- Investigators
- Jane Huggins, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117727
- Sponsor's protocol ID
- I0003 - AT SMR Switch Control
- Other IDs
- 5R21HD054697
- Status last verified
- Jun 2015
- First submitted
- 4 May 2010
- Last updated
- 15 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensorimotor Rhythm Brain-Computer Interface Switch to Operate Assistive Technology
- ClinicalTrials.gov ID
- NCT01117727
- Acronym / sponsor ID
- I0003 - AT SMR Switch Control
- Conditions
- Healthy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Performance of BCI switch insufficient in pilot testing.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 5 May 2010 (estimated)
- Results
- Posted 15 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to develop tools to help people who are paralyzed. These tools are called brain-computer interfaces (BCIs). BCIs would allow a person to use brain signals to operate technology. Specifically this project's goal is to design a BCI to operate a switch.
Detailed description
The investigators want to make a BCI that can be used to operate commercially available technologies for communication, environmental control or computer access. The BCI would replace a switch to let people operate these technologies without moving. However, investigators need people to test the BCI so they can determine how effective it is in replacing a switch.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot Testing | Experimental | Device: Brain Computer Interface Switch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- Able to read text on a computer screen
- Able to understand and remember instructions concerning participation
Key exclusion criteria (5 listed)
- Unable to give informed consent
- Unable to understand and follow instructions
- Have abnormal tone or uncontrolled movements in the head-and-neck that would interfere with EEG recordings
- Known to have photosensitive epilepsy
- Open head lesions or sores
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Computer Interface SwitchSubjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 14-20 sessions. | Device | Pilot Testing |
Primary outcome
Accuracy of Using the BCI as a Switch to Select From 4 Targets Using Scanning
Time frame: 8 sessions over 2 months
Average accuracy for selecting one of 4 targets with a switch operated by a brain-computer interface controlled by power in the sensorimotor rhythms. The 8 sessions were conducted over a 2 month period. Accuracy was calculated as the percentage of trials in which the target was correctly selected. Trials for all sessions were combined to create the overall average. Therefore, there is no standard deviation. .
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Huggins, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Brain Computer Interface Switch in people with Healthy, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Using the BCI as a Switch to Select From 4 Targets Using Scanning (time frame: 8 sessions over 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2015.